Kornimate/medical-research-clean huggingface dataset:
assessment of safety and efficacy of ccp

Conditions: Covid19

Summary: currently there are no proven treatments or vaccines for covid-19 and care of the covid patients is largely supportive involving treatment of symptoms such as fever with antipyretics, secondary bacterial chest infection with antibiotics and meticulous management of comorbid conditions. several repurposed and new drugs have been investigated for treatment of covid-19, however, none have been confirmed to be efficacious. these drugs include the antimalarials (chloroquine and hydroxychloroquine), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such lopinavir/ritonavir. there is emerging evidence to support the use of covid convalescent plasma for the treatment of covid-19. there is need to leverage the blood transfusion services in countries and this is beginning to happen on the continent.

currently there are no proven treatments for covid-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. while treatments are being investigated in the western world, it is likely that these data will take several months to become available and if proven to be efficacious, access in most of the low-income countries will be limited due to the high global demand and exorbitant costs. in this study, the investigators aim to assess the safety and efficacy of use of ccp for treatment of adults with covid-19 in uganda. the investigators hypothesise that administration of ccp to patients with positive sars-cov-2 rt pcr leads to earlier time to viral clearance compared to the standard of care. objectives: general objective the overall objective of this project is to assess the safety and efficacy of covid-19 convalescent plasma in the treatment of covid-19 in uganda. primary objective 1. to determine the efficacy of covid-19 convalescent plasma, as measured by time to rt-pcr negativity of covid-19 patients treated with covid-19 convalescent plasma. secondary objectives 1. to assess the safety of covid-19 convalescent plasma in the treatment of covid-19 patients in uganda 2. to document the time to symptom decrease of patients with positive sars-cov-2 rt pcr treated with ccp compared to those on standard of care 3. to assess the ability of ccp therapy to stop progression to severe/critical forms of disease this study will be a prospective randomized two arm open label clinical trial. patients with confirmed covid-19 who meet the study eligibility criteria will be randomized to receive either ccp in addition to standard of care therapy or standard of care therapy alone.

Eligibility criteria:
inclusion criteria: * adults with documented laboratory rt pcr confirmed sar-cov-2 infection * patients able to provide informed consent. in the event that the patient cannot provide consent e.g. they are severely sick, the next of kin or legal surrogate decision make exclusion criteria: * prior diagnosis of iga deficiency * inability to return for post discharge follow up
does oral pentoxifylline administration improve hemoglobin in hemodialysis patients?

Conditions: Anemia of Chronic Kidney Disease

Summary: our study investigated the effect of using a known drug used in intermittent claudication (named pentoxifylline) as an adjuvant to erythropoietin stimulating agents to improve anemia of hemodialysis patients.

fifty out of 57 hemodialysis anemic patients were finally included. they were assigned to two groups of equal numbers. oral pentoxifylline 400mg once daily was added to the treatment group which was compared to the control group over a six months period regarding hemoglobin, hematocrit, serum albumin and crp. inclusion criteria: (patients with esrd on hd who have hemoglobin \ 65%.). there were 57 patients who met the inclusion criteria out of 158 patients. exclusion criteria: iron deficiency anemia with transferrin saturation \ 300pg/ml, vitamin b12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.

Eligibility criteria:
inclusion criteria: * (patients with esrd on hd who have hemoglobin \ 65%.). there were 57 patients who met the inclusion criteria out of 158 patients exclusion criteria: * iron deficiency anemia with transferrin saturation \ 300pg/ml, vitamin b12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.
influence of weight loss or exercise on cartilage in obese knee osteoarthritis patients

Conditions: Osteoarthritis, Knee; Obesity

Summary: obesity and osteoarthritis (oa) co-exist in an increasing part of the population. the two diseases intertwine in several ways. the evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. the two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle. there is a link between treatments of these two diseases as well. there is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring oa, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. the long-term efficacy of a weight loss remains to be shown. oa is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. this trial has two phases, the first (16 weeks) consisting of a dietary intervention with low-energy diet and the second (52 weeks) a randomized, three group (each n\>50 patients) controlled study of maintenance of weight loss by either continuing dietary instruction, exercise, or a control group. the hypothesis is that maintenance of an initially induced weight loss is dependent on attention rather than any specific therapy.

any patient with osteoarthritis (oa)of the knee and concomitant obesity will be considered for participation. eligible for this study will be patients with radiographical knee oa. exclusion criteria are recent or planned knee operations, alloplasties in both knees, ongoing or planned alternative interventions against obesity.

Eligibility criteria:
inclusion criteria: * bmi \>=30 * radiographical knee oa * age \>=50 * spoken danish * motivated for weight loss exclusion criteria: * bilateral alloplasty of the knees * ongoing or planned surgery * ongoing or planned alternative weight loss programme * intellectual disability

Keywords: osteoarthritis obesity weight loss dietary instruction exercise attention
actigraphs for detection of asymmetries

Conditions: Hemiplegia; Hemiplegic Cerebral Palsy

Summary: in hemiplegia quantitatively measurement of the asymmetry in the use of upper limbs could overcome the limitation of many outcome measures in which scores are dependent on the experience and training of the therapist. the main aim of this study was to determine the validity of actigraph gxt3+ to measure asymmetry in the use of the two upper limbs during the assisting hand assessment (aha) in children, adolescents and young with hemiplegia aged 5-19 years, compared to age-matched typically developing subjects (td).

this study aims to validate the use of actigraphs as an evaluation tool of the upper limb asymmetry in children / adolescents and young adults with typical development or hemiplegia. the validation involves two stages: the first stage, carried out in the clinical setting, provides the use of actigraphs (actigraph gxt3+ and in a subgroup also fitbit) during the administration of clinical tests which are usually performed for the evaluation of the manual dominance in individuals with hemiplegia but also suitable for those with typical development. this first phase will allow to compare the quantitative measures acquired by the actigraphs (e.g. the mean activity of each hand and the asymmetry index i.e. difference between the mean activities of the two arms) with those from clinical standardized measures. the second phase, carried out in a non-clinical setting, provides the use of actigraphs (actigraph gxt3+ and in a subgroup also fitbit) in a subgroup of subject involved in the first phase for a week in order to measure the asymmetry index during the activities of daily living.

Eligibility criteria:
inclusion criteria: * age between 3-25 years * hemiplegia (experimental group) or voluntary adhesion (control group) exclusion criteria: * movement disorders * sensory deficits

Keywords: upper limb inertial sensors
rifaximin for the secondary prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients

Conditions: Spontaneous Bacterial Peritonitis

Summary: the aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.

* rifaximin is an antibiotic with a broad-spectrum activity against gram-positive and gram-negative microorganisms, both aerobes and anaerobes within the gastrointestinal tract. the main advantage of rifaximin is that it is poorly absorbable, which minimizes the antimicrobial resistance and adverse events and renders the drug safe in all patient populations. in addition, rifaximin has a better activity against gram-positive organisms than norfloxacin. * the appreciation of the potential role of enteric flora in the pathogenesis of several gastrointestinal diseases has broadened the clinical use of rifaximin, which is now used for hepatic encephalopathy, small intestine bacterial overgrowth, inflammatory bowel disease, and clostridium difficile infection. theoretically, by reducing the total number of the gut bacteria, rifaximin could also be used to achieve intestinal decontamination in patients with liver cirrhosis and ascites, thus preventing spontaneous bacterial peritonitis. * a small retrospective study concluded that rifaximin suppresses intestinal bacterial overgrowth, bacterial translocation in cirrhotic patients with ascites with no history of previous spontaneous bacterial peritonitis episodes. prospective clinical trials are warranted to evaluate the role of rifaximin for prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients.

Eligibility criteria:
inclusion criteria: * patients diagnosed with cirrhosis based on clinical, biochemical, ultrasonographic and/or histological criteria * patients who had recovered from an episode of spontaneous bacterial peritonitis * age \> 18 and \<80 years exclusion criteria: 1. decompensated cirrhotic patients with * serum bilirubin \> 3.2 mg/dl * prothrombin time \< 25% * serum creatinine \> 3 mg/dl 2. active gastrointestinal bleeding 3. hepatic encephalopathy \> grade 2 4. patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma

Keywords: liver cirrhosis ascites spontaneous bacterial peritonitis recurrence
peer support dyads in churches

Conditions: Peer Support and Chronic Disease; Obesity; Type II Diabetes; Cardiovascular Disease; Cancer

Summary: the purpose of this study is to explore how working with a partner can influence participation in a church wellness program. there are many different types of church wellness programs. church members are more likely to participate and achieve goals in these programs when they have peer support. the researcher would like to know what african american men and women think about working with a support partner. this information will help researchers design better church wellness programs. the participants are being asked to take part in this research because the investigators believe that it is helpful to share feelings and thoughts about experiences working with a partner to achieve health goals. this knowledge will be used to create church wellness programs that will help african american men and women prevent disease and live healthier lives.


Eligibility criteria:
inclusion criteria: * the inclusion criteria will be churches with mostly african american members. * participant criteria will be: ages \>=18 or older who identify as african american * attend church at least once per week * speak, read and write english * willing to complete study activities and assessments * able to engage in moderate physical activity. (e.g., walking - based on their own activity level and assessment). exclusion criteria: -

Keywords: african american faith institutions dyads health disparities
pharmacokinetics, pharmacodynamics, safety, and tolerability of empagliflozin in chinese female and male patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple oral doses of bi 10773 at low dose once daily (q.d.) and high dose q.d. administered to chinese female and male patients with type 2 diabetes will be investigated.


Eligibility criteria:
inclusion criteria: 1. chinese male and female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidinediones with at least one agent taken at 50% of its maximum dose or less, unchanged for at least 12 weeks before randomization 2. glycosylated haemoglobin a1(hba1c)\ =7.0% at screening,age\>=21 and age\ =19 and \<=40 kg/m2 3. signed and dated written informed consent by date of visit 1 in accordance with gcp and local legislation. exclusion criteria: 1. patient who did not discontinue the antidiabetic treatment with insulin or glitazones, dpp-iv at least before 12 weeks before randomization 2. uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/l) after an overnight fast at screening visit 3. clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as: 4 any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) 5 renal insufficiency (calculated creatinine clearance \ 160/95mmhg (measured at training visit and each of the timepoints of day -1), stroke and tia 7 neurological disorders (such as epilepsy) or psychiatric disorders 8 acute or relevant chronic infections (e.g. hiv, repeated urogenital infections) 9 any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 10. history of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 11. a marked baseline prolongation of qt/qtc interval (e.g., ecg demonstration of a qtc interval \>450 ms ) at screening visit
gait analysis in females suffering from patellofemoral pain syndrome (pfps)

Conditions: Patellofemoral Pain Syndrome

Summary: the purpose of the study was to evaluate the spatial and temporal variables during walking cycle in adolescent females suffering from patellofemoral pain syndrome (pfps) versus healthy adolescent females .


Eligibility criteria:
inclusion criteria: * peripatellar or retropatellar knee pain worsen with upstairs and walking exclusion criteria: * previous knee or patella surgeries
the effect of eft on psychological states in a veterans population

Conditions: Stress Disorders, Post-Traumatic

Summary: a need exists to find fast yet effective treatment protocols for the large number of us military service personnel coming back from iraq with post traumatic stress disorder (ptsd), and a variety of co-occurring psychological problems. eft (emotional freedom techniques) has demonstrated promise as a ptsd treatment in pilot studies. this study examines the effects of six sessions of eft coaching on veterans who score at or above the military cutoff point for pstd. subjects are also assessed for conditions that often accompany ptsd, such as depression and anxiety. changes pain, cravings, and physical symptoms are also measured. assessments are made after six sessions are complete, and again after three and six months.

a need exists to find fast yet effective treatment protocols for the large number of us military service personnel coming back from iraq with post traumatic stress disorder (ptsd), and a variety of co-occurring psychological problems. this study examines the effects of six sessions of eft coaching on a veterans population. the sample will recruited from clients of practitioners who are coaching veterans. participants will be assessed for ptsd and other psychological conditions such as anxiety and depression. evaluations will be made using well-validated instruments, the sa-45 (symptom assessment 45) and the pcl-m (posttraumatic stress disorder checklist - military). those meeting the military's criterion for a ptsd-positive assessment on the pcl-m will be randomized into two groups. a wait list control group continues to receive standard of care (soc) from their current healthcare provider. the experimental group receives soc plus eft coaching. a baseline measurement is obtained approximately thirty days in advance of coaching, when subjects apply to participate in the study, and again immediately before coaching begins. participants are assessed after three sessions and six sessions, to determine symptom changes at these milestones. followup assessments occur three months and six months post-coaching. pain levels, alcohol use, recreational drug use, and prescription drug dosages are also tracked, in order to determine any correlation between participant characteristics and psychological symptom change. data will also be analyzed to determine if there are outcome differences between participants receiving eft from life coaches, and those whose eft coaching is delivered by licensed psychologists or social workers.

Eligibility criteria:
inclusion criteria: * military service * score of 50 or more on the pcl-m (ptsd checklist-military) * the ability to follow instructions and complete written forms * under the care of a primary care provider exclusion criteria: * a score of 3 or more on questions 34 and 35 of the sa-45

Keywords: ptsd, eft, depression, anxiety, telephone
preliminary feasibility and efficacy of behavioral intervention to reduce pain-related disability in pediatric scd

Conditions: Sickle Cell Disease; Pain

Summary: pain is the primary complication of sickle cell disease (scd), including vaso-occlusive crises and more persistent, chronic pain. scd-related pain is associated with significant functional impairment, spanning poor school attendance, decreased quality of life, and stress and mood difficulties. pharmacological approaches are the first-line treatment for scd-related pain, but these can be costly and have unwanted side effects. given limitations from pharmacological approaches and the influence that poor behavioral responses have on disease management and health outcomes suggest a critical need for alternative and adjunctive treatments. due to gaps in available behavioral treatments specifically designed for addressing common challenges associated with pain management in pediatric scd, the investigators developed a manualized behavioral therapy protocol by tailoring existing evidence-based treatments. the overall goal of the intervention is to reduce the impact of pain on daily functioning in pediatric scd. this study will empirically test the feasibility and preliminary efficacy of this intervention for youth with scd. children and adolescents with scd between the ages of 8 and 17 years old (n=20) will be recruited to complete the treatment protocol. feasibility will be assessed by examining participation and program completion rates, as well as feedback from a treatment acceptability questionnaire and qualitative interview. participants will complete baseline assessments, weekly questionnaires, and post-treatment assessments (post-intervention assessment, follow-up time points: 1-month following the intervention, and 3-months following the intervention).


Eligibility criteria:
inclusion criteria: * children and adolescents with scd (hbss, hbsc, hbs-beta0 thalassemia, or hbs-beta+ thalassemia) between the ages of 8 and 17 years old with pain-related disability and who are currently prescribed short- or long-acting opioid medications. 1. participants will meet at least one of the following criteria for pain-related disability: 1) have had at least 3 pain crises in the last year, 2) have had at least one admission for pain in the last year, or 3) have missed at least one week of school (5 days) in the last year 2. current prescription of opioids will be confirmed by participants' primary hematologist, review of the electronic medical record, and discussion with the family. exclusion criteria: * patients and caregivers with limited english proficiency, a neurodevelopmental delay, or a visual or motor impairment that would interfere with their ability to complete the assessments and intervention. * documented history of major depressive disorder in medical record and/or through discussion with their primary hematology suggesting that patients may need a specific and higher level of therapeutic care. * patients have regularly scheduled outpatient therapy sessions outside of the study.
long-term study with trazodone once-a-day

Conditions: Major Depressive Disorder

Summary: the aim of the present observational study is to assess the clinical response, functional impairment and quality of life in outpatients with major depressive disorder who demonstrated an initial positive response to the acute treatment with trazodone once-a-day monotherapy, for up to 24 weeks.

this is an observational, prospective, single group, multicentre, international study. the present study is planned to assess, in a real-world setting, the long-term clinical response, functional impairment and quality of life in outpatients with major depressive disorder who, according to the physician's judgment, have responded to the acute monotherapy (6 to 8 weeks of treatment) with trazodone once-a-day and are eligible to continue trazodone once-a-day monotherapy according to clinical practice.

Eligibility criteria:
inclusion criteria: male and female patients of any ethnic origin ≥18 years old at baseline. outpatients who meet the diagnostic and statistical manual of mental disorders (dsm)-5 or the international classification of diseases (icd)-10 criteria for mdd as their primary diagnosis and presenting with an episode of mdd. patients judged as responders to the acute monotherapy with tzoad after a minimum of 6 and a maximum of 8 weeks of treatment and who are eligible to continue the assigned monotherapy according to the physician's judgement. patients legally capable of giving their written consent for participation in the study and for personal data processing and willing to comply with all study procedures. exclusion criteria: patients that meet any of the contraindications to the administration of tzoad according to the approved smpc. patients with previous or current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, dysthymic or adjustment disorders, mental retardation, organic mental disorders or mental disorders due to a general medical condition. patients with previous or current history of a clinically significant neurological disorder, or any neurodegenerative diseases that might compromise the participation in the study. patients who are, according to the physician's judgement, at serious risk of suicide. patients with substance abuse or dependence (except nicotine dependence), as defined by dsm-5. patients participating in any pharmacological or non-pharmacological interventional study.

Keywords: trazodone once-a-day major depressive disorder long term therapy